Name: Predicase
Price: 199 USD

K-number	K251289
Device name	WELLlife COVID-19 Antigen Test Rx
Applicant	Guangzhou Wondfo Biotech Co., Ltd.
Product code	QVF
Device class	Class II
Decision date	Oct 22, 2025
Decision	Substantially Equivalent
Regulation	866.3982

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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WELLlife COVID-19 Antigen Test Rx

Everything you need for a 510(k) submission. Nothing you don't.